PHILADELPHIA – Taking pharmaceutical formulation cannabidiol, Konoplev medicine to reduce seizures almost doubled for children with rare and severe type of epilepsy called Dravet syndrome, according to the phase 3 study released today that will be presented at the American Academy on the 71st Neurology's annual meeting in Philadelphia on may 4 to 10, 2019. Dravet syndrome, which begins in childhood, can lead to mental retardation and frequent, prolonged seizures. Cannabidiol is derived from marijuana, which does not include the part of the psychoactive plant that produces a "high".
"It's exciting to be able to offer another alternative for children with this debilitating form of epilepsy and seven & # 39; ads," says study author Ian Miller, MD, Children's Hospital Nicklaus, a former Miami Children's Hospital in Florida. "The children in this study had already tried an average of four epilepsy medications without success, and then took an average of three additional drugs, so that this measure of success with cannabidiol major victory."
The study involved 199 children with an average age of 9, who were divided into three groups. One group received 20 mg per kilogram (mg / kg) per day cannabidiol, the second group received 10 mg / kg per day, and the third group received a placebo.
Attacks were recorded during the four weeks before the procedure was initiated to establish a baseline. Then participants were treated for 14 weeks. By the end of the study, seizures, convulsions decreased for those who take a high dose of the drug by 46 percent and 49 percent for those taking lower doses of the drug, compared with 27 percent for those who took a placebo.
The total number of seizures have decreased by 47 percent for those in the high dose group, by 56 percent for those in the lower dose group, and 30 percent for those on placebo. In the high dose group, 49 percent of the participants have their seizures cut in half or more, compared to 44 percent in the low-dose group and 26 percent in the placebo group.
All groups were reported about the side effects, with 90 percent of the high dose group, 88 percent low-dose group and 89 percent in the placebo group. The most common side effects were decreased appetite, diarrhea, drowsiness, fever and fatigue. About 25 percent of those in the high dose group had a sur & # 39; serious side effects, compared to 20 percent in the low dose group, and 15 percent in the placebo group. Only members of high dose stopped taking drug because of side effects; the figure was 7 percent.
"Based on these results, increasing the dose above 10 mg / kg per day should be carefully considered on the basis of efficacy and safety for everyone," said Miller.
The study was supported by GW Research Ltd, the developer of cannabidiol. In the United States, GW operates through its subsidiary, Greenwich Biosciences, Inc.
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